Clinical Trial Phase I/II Prospective, Open Nonrandomized for Treatmen of Postoperative Air Leak After Lung Resection in High Risk Patients Through the Administration of Mesenchymal Autologous Cells

NCT02045745 | Unknown Phase 1

• 2 other identifiers: CSM/FAP/20122013-000535-27
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to analyze the safety and feasibility of the implantation of autologous mesenchymal stem cells (MSCs) expanded "in vitro" and administered directly in the lung line of suture as a treatment for patients at risk of postoperative air leaks after lung resection.

Conditions

Postoperative Air Leaks in Risk Patients

Keywords

Postoperative air leaks in risk patients.

Outcome Measures

Primary Outcomes (1)

• Safety of the procedure

  Security is measured in terms of: Adverse effects derived from the implantation of the CSM

  During the procedure and postoperative period (48 hours)

Secondary Outcomes (1)

• Analyze the efficacy of the procedure

  Postoperative period (48 hours), 1 month, 3 months, 6, 12 and 24 months

Study Arms (1)

Prolonged postoperative air leaks in risk patients.

EXPERIMENTAL

Patients with prolonged postoperative air leaks

Biological: Implantation of autologous mesenchymal stem cells (CSM) expanded "in vitro" and administered directly into the lung suture line

Interventions

Implantation of autologous mesenchymal stem cells (CSM) expanded "in vitro" and administered directly into the lung suture line BIOLOGICAL

Patients at risk of prolonged postoperative air leak will be treated by local administration of autologous mesenchymal cells expanded in vitro

Prolonged postoperative air leaks in risk patients.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70 years
• Patients who will be subjected to programmed anatomic lung resection (pneumonectomy excluded)

You may not qualify if:

• Those considered by the investigator are not on a good position to tolerate the procedure
• Clinical criteria and anesthetics that contraindicate surgery
• Uncontrolled severe disease
• Pregnant women
• Patients infected with hepatitis B, hepatitis C, syphilis and HIV + virus
• People who are taking a drug under clinical investigation or participated in any study under clinical investigation (or an authorized product) within 30 days prior to randomization
• The absence of informed consent or revocation thereof

Sponsors & Collaborators

• Red de Terapia Celular: lead
• Castilla y León Hematology and hemotherapy Foundation: collaborator
• Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán: collaborator
• Spanish National Health System: collaborator

Study Sites (1)

University Clinical Hospital of Salamanca

Salamanca, Salamanca/Castilla León, 37007, Spain

RECRUITING

Related Publications (1)

• Jimenez MF, Gomez-Hernandez MT, Villaron EM, Lopez-Parra M, Sanchez-Guijo F. Autologous mesenchymal stromal cells embedded with Tissucol Duo(R) for prevention of air leak after anatomical lung resection: results of a prospective phase I/II clinical trial with long-term follow-up. Stem Cell Res Ther. 2023 Oct 31;14(1):313. doi: 10.1186/s13287-023-03545-8.

  PMID: 37904229 DERIVED

Study Officials

• Marcelo F Jiménez López, Ph.D

  University Clinical Hospital of Salamanca

  PRINCIPAL INVESTIGATOR

• Gonzalo Varela Simó, Ph.D

  University Clinical Hospital of Salamanca

  STUDY CHAIR

• Nuria M Novoa Valentín, Ph.D

  University Clinical Hospital of Salamanca

  STUDY CHAIR

• José L Aranda Alcaide, Ph.D

  University Clinical Hospital of Salamanca

  STUDY CHAIR

• Consuelo del Cañizo, Ph.D

  University Clinical Hospital of Salamanca

  STUDY DIRECTOR

• Fermín Sánchez-Guijo Martín, Ph.D

  University Clinical Hospital of Salamanca

  STUDY CHAIR

• Olga López Villar, Ph.D

  University Clinical Hospital of Salamanca

  STUDY CHAIR

• Eva M Villarón Ríos, Ph.D

  University Clinical Hospital of Salamanca

  STUDY CHAIR

Central Study Contacts

Fermín Sánchez-Guijo Martín, Ph.D

CONTACT

+34923294624; ferminsg@usal.es

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 27, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 30, 2017

Record last verified: 2017-03

Locations

ES (1)